Nyhet - 25 November 2014 10:24

Impressive results in new Vaccine publication

Although ETEC is the most frequent bacterial cause of diarrhea in children in developing countries and the major cause of travelers’ diarrhea, no vaccine is yet available against ETEC disease. In a recently published article in Vaccine the clinical phase I results with our new oral vaccine against ETEC is presented. The objectives of this study were to evaluate the safety and mucosal immunogenicity of the vaccine and to explore if the immunogenicity of the vaccine might be further enhanced by addition of double-mutant heat-labile toxin (dmLT) adjuvant.

The results show that the vaccine was safe, well tolerated and broadly immunogenic – a result that highly exceeded the expectations. Based on the excellent safety profile and the capacity of the vaccine to induce highly significant mucosal immune responses against the most prevalent ETEC virulence factors, the vaccine will be tested for safety and immunogenicity in different age groups including infants in Phase I/II trials in Bangladesh during next year and for protective efficacy in travelers/visitors to ETEC-endemic areas the year after.

The full text article can be found on doi:10.1016/j.vaccine.2014.10.069.

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Scandinavian Biopharma announces successful results in placebo-controlled Phase I study of an oral, inactivated vaccine against diarrhea for travelers and children in developing countries

Travelers’ diarrhea is the leading cause of illness among international travelers to developing countries. ETEC bacteria are the primary cause of this disease. ETEC is also a major cause of diarrheal disease among children living in endemic countries. A clinical Phase I study of a novel vaccine against diarrhea caused by ETEC has been successfully completed. All primary endpoints were achieved.

Scandinavian Biopharma and PATH sign amendment to collaborative agreement to develop a vaccine against diarrhoeal disease

Enterotoxigenic Escherichia coli (ETEC) bacteria are responsible each year for around 400 million cases of diarrhoea and hundreds of thousands of deaths in low- and middle-income countries. Scandinavian Biopharma holds global rights to commercialize the product and will support PATH in its goal to make the product affordable and available in low-resource countries.

Vi är ett forskningsbaserat biotechföretag fast beslutna att ge människor i hela världen ett längre och bättre liv.

Vi utvecklar det första vaccinet i världen mot diarré orsakad av ETEC för att skydda både barn och vuxna i endemiska länder och resenärer till högriskdestinationer.

Vi distribuerar ett brett sortiment av biologiska specialistläkemedel med fokus på vacciner och immunglobuliner.

www.scandinavianbiopharma.se

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Impressive results in new Vaccine publication

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Björn Sjöstrand

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Scandinavian Biopharma announces successful results in placebo-controlled Phase I study of an oral, inactivated vaccine against diarrhea for travelers and children in developing countries

Scandinavian Biopharma and PATH sign amendment to collaborative agreement to develop a vaccine against diarrhoeal disease

Vi är ett forskningsbaserat biotechföretag fast beslutna att ge människor i hela världen ett längre och bättre liv.